Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus

AJU Pharm Co., Ltd.1 site in 1 country235 target enrollmentApril 27, 2021

ConditionsType2 Diabetes

InterventionsA51R3 AJU-A51 A51R2 Placebo A51R2 AJU-A51 Placebo

DrugsAJU-A51 A51R2 A51R3 AJU-A51 Placebo A51R2 Placebo

Overview

Phase: Phase 3
Intervention: A51R3
Conditions: Type2 Diabetes
Sponsor: AJU Pharm Co., Ltd.
Enrollment: 235
Locations: 1
Primary Endpoint: Changes in HbA1c
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2

Registry

clinicaltrials.gov

Start Date

April 27, 2021

End Date

June 13, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AJU Pharm Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Those who voluntarily signed the informed consent to participate in this study.
•Adults aged 19-75 years.
•Those diagnosed with type 2 diabetes mellitus.
•7% ≤ HbA1c ≤ 10.5%
•FPG ≤ 270 mg/dL
•BMI ≤ 40 kg/㎡
•Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.

Exclusion Criteria

•Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
•Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
•Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure.
•Those with a history of malignant tumor within 5 years
•Those who have a clinically significant liver disease
•Those who have a clinically significant renal disease
•SBP \> 180 mmHg or DBP \> 110 mmHg
•Those who had allergic reaction to main ingredients or components of the investigational products.
•Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
•Females who are pregnant or breastfeeding.